Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health -

The innovation of medical IT has the potential to save lives, but even a small “glitch” can harm patients. Our study found hundreds of recalls of flawed devices that affected millions of patients. Examples include electronic medical records that provide info about the wrong patient and “physician support” devices that miscalculate the dosage of medication. But the FDA is set to deregulate these devices.

Statement of Dr. Diana Zuckerman in honor of Dr. Vivian Pinn -

September 8, 2017. I am going to Charlottesville on September 13 to honor Dr. Vivian Pinn, our 2013 Foremother Awards honoree, as a major UVA medical school building is named in her honor.  Dr. Pinn received her medical degree from the University of Virginia in 1967, where she was the only African-American and only woman in her graduating class.

Will Controversial Bill Cure or Kill Patients? -

Who What Why, September 7, 2017. Diana Zuckerman, president of the National Center for Health Research, points out that drug companies rely on a three-phase clinical trial process to gain FDA approval for their products. If RTT siphoned off patients with life-threatening illnesses from clinical trials, particularly for trials of medications serving limited populations with rare diseases, drug companies might find it even harder to enroll enough patients to complete them. And health insurers will not pay for drugs that lack FDA approval.